How filtration changes patients' own serum used as eye drops
Optimization of Autologous Serum Eye Drops: Study of Filtration on Active Molecule Concentration in Patients With Dry Eye Disease (IFilCoSA)
This project will test whether filtering a patient's own blood serum changes levels of healing molecules in autologous eye drops for people with severe dry eye who haven't responded to usual treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Limoges Academic / other |
| Locations | 1 site (Limoges) |
| Trial ID | NCT07407101 on ClinicalTrials.gov |
What this trial studies
This pilot will enroll ten adults with severe dry eye at CHU Limoges who have not improved with conventional therapies. Blood will be drawn, sera separated by coagulation and centrifugation, and multiple aliquots prepared; aliquots will then undergo different filtration steps (including clarifying and sterilizing porosities) to compare composition before and after filtration. Laboratory assays will quantify five key molecules—EGF, TGF-β, IGF-1, fibronectin and vitamin A—and report absolute and relative differences induced by filtration. Only patients with negative serology for HIV, HBV, HCV and syphilis will be included and samples will be processed at the hospital's Pharmaceutical Preparations Unit.
Who should consider this trial
Good fit: Adults treated at the CHU Limoges ophthalmology department with severe dry eye not helped by conventional therapies, covered by health insurance, able to give written consent, and with negative HIV/HBV/HCV/syphilis serology.
Not a fit: Patients with positive serology for HIV/HBV/HCV or syphilis, those with mild dry eye who do not need autologous serum drops, or those unable to attend in-person blood collection are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, results could help standardize a safe, sterile preparation method that preserves therapeutic molecules in autologous serum eye drops and improve treatment consistency for severe dry eye.
How similar studies have performed: Previous reports have described serum components, but most omit sterilizing filtration and the specific impact of filtration on key therapeutic molecule levels is largely untested, so this is an exploratory pilot.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult patients * patients covered by health insurance * patients managed by the Ophtalmology Department of the University Hospital of Limoges * patients diagnosed with dry eyes syndrome, who have not responded to conventionnal treatments * free, informed, written and signed consent Exclusion Criteria: * person incapable of consent * legal guardianship or wardship * patient who does not wish to know the results of serological tests Secondary exclusion criteria: \- a positive serology for at least of of the following agents (HIV, HCV, HBV or syphilis)
Where this trial is running
Limoges
- CHU Limoges — Limoges, France (Recruiting)
Study contacts
- Principal investigator: Maxime Rocher, Dr — University Hospital, Limoges
- Study coordinator: Safirah Akowanou
- Email: safirah.akowanou@chu-limoges.fr
- Phone: 05 55 05 87 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.